Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-02
Brief Title:
Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
European Prospective Multicentre Open Trial Comparing Cataract Surgery With Triple-DMEK in Patients With Cataract and Fuchs Endothelial Corneal Dystrophy ETCF-trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate whether there is a difference in best spectacle corrected visual acuity BSCVA in patients treated with one of the following two surgeries 1 cataract surgery with preservation of the diseased endothelial cells cataract surgery only experimental intervention investigational therapy arm 1 2 cataract surgery combined with removal of the diseased endothelial cells and the attached Descemets membrane followed by transplantation of a healthy endothelial cell layer with attached Descemets membrane triple-DMEKcataract surgery only control intervention comparator therapy arm 2
Detailed Description:
After signing the informed consent patients are screened for eligibility for the trial regarding in- and exclusion criteria Different tests will be performed like ocular examination including slit lamp examination fundus examination IOP measurement BSCVA Pentacam imaging contrast sensivity test and Macula-OCT vital signs
Once all inclusion criteria and none of the exclusion criteria are met the patient will be enrolled into the trial and will receive a subject-ID
If Screening and Baseline assessments cannot be performed on the same day a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial At the Baseline Visit different tests will be performed like a Fluorescein stain test In addition subjects have to complete vision related quality of life questionnaires
After all investigations are completed the subject will be randomised and distributed to the respective treatment groups
Patients who are enroled in arm 1 undergo exclusively a cataract surgery in the comparator therapy arm 2 patients undergo triple-DMEK cataract surgery and DMEK
The post-operative Visit will take place 22 weeks 14 days after the surgical intervention where different test have to be performed
The duration of the clinical trial for every individual subject will be up to 24 weeks
Once all inclusion criteria and none of the exclusion criteria are met the patient will be enrolled into the trial and will receive a subject-ID
If Screening and Baseline assessments cannot be performed on the same day a Baseline Visit can take place up to 7 days after enrolment of the subject into the clinical trial At the Baseline Visit different tests will be performed like a Fluorescein stain test In addition subjects have to complete vision related quality of life questionnaires
After all investigations are completed the subject will be randomised and distributed to the respective treatment groups
Patients who are enroled in arm 1 undergo exclusively a cataract surgery in the comparator therapy arm 2 patients undergo triple-DMEK cataract surgery and DMEK
The post-operative Visit will take place 22 weeks 14 days after the surgical intervention where different test have to be performed
The duration of the clinical trial for every individual subject will be up to 24 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ORG-100006227 | OTHER | ESCRS European society of Cataract and Refractive Surgeons | None |